Cefprozil 250mg/5ml Susp 75ml
It is used to treat bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Second-generation cephalosporin
Pregnancy Category
Category B
FDA Approved
Jan 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cefprozil is an antibiotic used to treat various bacterial infections, such as ear infections, sinus infections, throat infections, and skin infections. It works by stopping the growth of bacteria. It will not work for viral infections like the common cold or flu.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel better. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize this side effect.
Before using the liquid form of this medication, shake the bottle well. To ensure accurate dosing, measure the liquid carefully using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one.
Storing and Disposing of Your Medication
Store this medication in the refrigerator at all times. If you don't use the entire contents within 2 weeks, discard any remaining medication. Do not freeze this medication. Keep all medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel better. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize this side effect.
Before using the liquid form of this medication, shake the bottle well. To ensure accurate dosing, measure the liquid carefully using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one.
Storing and Disposing of Your Medication
Store this medication in the refrigerator at all times. If you don't use the entire contents within 2 weeks, discard any remaining medication. Do not freeze this medication. Keep all medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take the full course of medication as prescribed, even if symptoms improve, to prevent recurrence and development of antibiotic resistance.
- Shake the oral suspension well before each use.
- Measure the dose accurately using the provided measuring spoon or cup.
- Store the reconstituted suspension in the refrigerator and discard any unused portion after 14 days.
- Do not share this medication with others.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication (e.g., 500 mg q24h or 250-500 mg q12h)
Dose Range:
250 - 500 mg
Condition-Specific Dosing:
Pharyngitis/Tonsillitis:
500 mg q24h for 10 days
Acute Bacterial Sinusitis:
250 mg q12h for 10 days (mild/moderate) or 500 mg q12h for 10 days (severe)
Acute Bronchitis:
500 mg q12h for 10 days
Skin and Skin Structure Infections (uncomplicated):
250 mg q12h or 500 mg q24h for 10 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Otitis Media (6 months to 12 years): 15 mg/kg q12h for 10 days (max 1 g/day)
Child:
Pharyngitis/Tonsillitis (2-12 years): 7.5 mg/kg q12h for 10 days OR 20 mg/kg q24h for 10 days (max 500 mg/day); Otitis Media (6 months to 12 years): 15 mg/kg q12h for 10 days (max 1 g/day); Skin/Skin Structure (2-12 years): 20 mg/kg q24h for 10 days (max 500 mg/day)
Adolescent:
Generally adult dosing applies, consider weight and renal function.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 30 mL/min)
Moderate:
No adjustment needed (CrCl > 30 mL/min)
Severe:
Reduce dose by 50% (CrCl < 30 mL/min)
Dialysis:
Administer dose after hemodialysis (approximately 60% removed during 3-4 hour hemodialysis)
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
No adjustment
Pharmacology
Mechanism of Action
Cefprozil is a bactericidal antibiotic that acts by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, thereby inhibiting the third and final stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefprozil interferes with an autolysin inhibitor.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 95%
Tmax:
1.5 hours (fasted state)
FoodEffect:
Food delays Tmax by 0.5-1 hour and reduces Cmax by 25%, but the extent of absorption (AUC) is unaffected.
Distribution:
Vd:
Approximately 0.23 L/kg
ProteinBinding:
Approximately 36%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1.3 hours
Clearance:
Not available (primarily renal)
ExcretionRoute:
Renal (60-65% unchanged in urine)
Unchanged:
60-65%
Pharmacodynamics
OnsetOfAction:
Rapid
PeakEffect:
Within 1.5 hours (plasma concentration)
DurationOfAction:
Dependent on dosing interval (e.g., 12 or 24 hours)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some individuals may experience severe and potentially life-threatening side effects when taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Seizures
Diarrhea, particularly if it is severe and accompanied by:
+ Stomach pain
+ Cramps
+ Very loose, watery, or bloody stools
Note: Diarrhea is a common side effect of antibiotics, but in rare cases, it can lead to a severe condition called C. diff-associated diarrhea (CDAD), which may cause a potentially life-threatening bowel problem. CDAD can occur during or several months after antibiotic treatment. If you experience any of these symptoms, contact your doctor promptly. Before treating diarrhea, consult with your doctor.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not resolve, contact your doctor or seek medical help:
Upset stomach
* Diarrhea
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some individuals may experience severe and potentially life-threatening side effects when taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Seizures
Diarrhea, particularly if it is severe and accompanied by:
+ Stomach pain
+ Cramps
+ Very loose, watery, or bloody stools
Note: Diarrhea is a common side effect of antibiotics, but in rare cases, it can lead to a severe condition called C. diff-associated diarrhea (CDAD), which may cause a potentially life-threatening bowel problem. CDAD can occur during or several months after antibiotic treatment. If you experience any of these symptoms, contact your doctor promptly. Before treating diarrhea, consult with your doctor.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not resolve, contact your doctor or seek medical help:
Upset stomach
* Diarrhea
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of allergic reaction: rash, itching, hives, swelling of the face/lips/tongue/throat, severe dizziness, trouble breathing.
- Severe or watery diarrhea, especially if persistent or bloody (may indicate Clostridioides difficile-associated diarrhea).
- New signs of infection (e.g., fever, sore throat, vaginal itching or discharge, white patches in the mouth) which could indicate a superinfection.
- Unusual bruising or bleeding.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances.
* Any health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances.
* Any health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition.
If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable testing method for you, as this medication may affect the accuracy of certain tests. Additionally, be sure to notify all your healthcare providers and laboratory personnel that you are taking this medication, as it may interfere with the results of some lab tests.
Do not take this medication for longer than prescribed, as this may increase the risk of developing a secondary infection. If you have phenylketonuria (PKU), discuss this with your doctor, as some formulations of this medication may contain phenylalanine.
Older adults (65 years and older) should exercise caution when taking this medication, as they may be more susceptible to side effects. If you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to weigh the benefits and risks of taking this medication, both for you and your baby.
If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable testing method for you, as this medication may affect the accuracy of certain tests. Additionally, be sure to notify all your healthcare providers and laboratory personnel that you are taking this medication, as it may interfere with the results of some lab tests.
Do not take this medication for longer than prescribed, as this may increase the risk of developing a secondary infection. If you have phenylketonuria (PKU), discuss this with your doctor, as some formulations of this medication may contain phenylalanine.
Older adults (65 years and older) should exercise caution when taking this medication, as they may be more susceptible to side effects. If you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to weigh the benefits and risks of taking this medication, both for you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Abdominal discomfort
- In rare cases, seizures (especially in patients with renal impairment)
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Hemodialysis may be useful in removing the drug from the body.
Drug Interactions
Major Interactions
- Live bacterial vaccines (e.g., Typhoid vaccine, oral)
Moderate Interactions
- Probenecid
- Warfarin (and other oral anticoagulants)
- Aminoglycosides (potential for increased nephrotoxicity, though less common with cephalosporins)
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: To determine appropriate dosing, especially in elderly or renally impaired patients.
Timing: Prior to initiation of therapy
Culture and Sensitivity
Rationale: To confirm susceptibility of the causative pathogen to cefprozil.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection resolution
Frequency: Daily
Target: Improvement or resolution of fever, pain, inflammation
Action Threshold: Lack of improvement or worsening symptoms after 2-3 days may indicate treatment failure or resistant organism.
Signs of superinfection (e.g., oral thrush, vaginal candidiasis, severe diarrhea)
Frequency: Daily
Target: Absence of new infections
Action Threshold: Presence of new or worsening symptoms, especially severe diarrhea (consider C. difficile infection).
INR (if on warfarin)
Frequency: As clinically indicated, especially at initiation or discontinuation of cefprozil
Target: Therapeutic range for warfarin
Action Threshold: INR outside target range; adjust warfarin dose as needed.
Symptom Monitoring
- Rash
- Hives
- Difficulty breathing or swallowing (signs of allergic reaction)
- Severe or watery diarrhea
- Abdominal pain or cramps
- Fever
- Sore throat
- Unusual bleeding or bruising
- Yellowing of skin or eyes (jaundice)
Special Patient Groups
Pregnancy
Cefprozil is classified as Pregnancy Category B. Animal reproduction studies have shown no evidence of harm to the fetus. Human studies are limited, but it is generally considered safe for use during pregnancy when clearly needed.
Trimester-Specific Risks:
First Trimester:
No increased risk of congenital anomalies observed in animal studies.
Second Trimester:
Generally considered safe.
Third Trimester:
Generally considered safe.
Lactation
Cefprozil is excreted in human milk in very low concentrations. It is generally considered compatible with breastfeeding. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush), or allergic reactions (rash).
Infant Risk:
Low risk
Pediatric Use
Dosing is established for pediatric patients 6 months and older for specific indications. Safety and efficacy in infants younger than 6 months have not been established. Accurate weight-based dosing is crucial.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment is primarily based on renal function, which may be diminished in the elderly.
Clinical Information
Clinical Pearls
- Cefprozil is a second-generation cephalosporin effective against a range of Gram-positive and some Gram-negative bacteria, including common respiratory pathogens.
- It is often chosen for its convenient once- or twice-daily dosing.
- The oral suspension must be shaken well before each use and refrigerated after reconstitution.
- Patients should be advised to complete the entire course of therapy to prevent bacterial resistance and relapse.
- While generally well-tolerated, gastrointestinal side effects (diarrhea, nausea, vomiting) are common.
Alternative Therapies
- Other second-generation cephalosporins (e.g., cefuroxime, cefaclor, cefdinir)
- Penicillins (e.g., amoxicillin, amoxicillin/clavulanate)
- Macrolides (e.g., azithromycin, clarithromycin) for patients with penicillin allergy
- Other antibiotic classes depending on the specific infection and susceptibility.
Cost & Coverage
Average Cost:
Varies widely by pharmacy and insurance plan per 75ml suspension
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.